NCT01937156已完成3 期
A Randomized, Active-control, Double-blind, Double-dummy, Parallel-group, Multi-center Study to Assess the Efficacy and Safety of SP-01 (Granisetron Transdermal Delivery System) in Chemotherapy-induced Nausea and Vomiting Associated With the Administration of Moderately or Highly Emetogenic (ME or HE) Multi-day Chemotherapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 313
- 试验地点
- 1
- 主要终点
- Percentage of subjects achieving Complete Control (CC) of CINV from the first administration until 24 hour after the last administration of ME or HE multi-day chemotherapy
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of SP-01 in chemotherapy-induced nausea and vomiting (CINV) associated with the administration of moderately or highly emetogenic (ME or HE) multi-day chemotherapy，which will provide scientific and reliable clinical data in the drug registration in China.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female aged ≥ 18years
- •Histologically and/or cytologically confirmed cancer
- •The physical status score ECOG ≤ 2
- •Life expectancy of ≥3 months
- •Will receive multi-day ME/HE chemotherapy (≥2 days) with the emetogenic potential of level 3-5
- •In accordance with the indication of chemotherapy and basic requirements;
- •Peripheral Haematology: Hb ≥ 9.0 g/dL, absolute neutrophil count ≥ 1.5×10e9/L, platelet count ≥ 80×10e9/L
- •Blood biochemistry: Total bilirubin < 1.25×ULN, ALT and AST ≤ 2.5×ULN; if liver metastasis, ALT and AST < 5×ULN, Creatinine ≤ 1×ULN, basic normal serum electrolyte (Na, Ka, Cl, Ca)
- •Other important organs function normally
- •Subjects voluntarily participate and signed the informed consent form
排除标准
- 未提供
研究组 & 干预措施
SP-01
Experimental
干预措施: SP-01 (Granisetron Transdermal Delivery System) (Drug)
Granisetron Hydrochloride Tablet
Active Comparator
干预措施: Granisetron Hydrochloride Tablet (Drug)
结局指标
主要结局
Percentage of subjects achieving Complete Control (CC) of CINV from the first administration until 24 hour after the last administration of ME or HE multi-day chemotherapy
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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